OES CYSTONEPHROFIBERSCOPERecalls & reported problems across all models
Olympus Medical Systems Corp. · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
4 open recalls name at least one OES CYSTONEPHROFIBERSCOPE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,010
- Deaths reported
- 1
- Injuries reported
- 87
- Recalls
- 4
We found 9 models of OES CYSTONEPHROFIBERSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 1,010 adverse event reports in the FDA's MAUDE database, received between May 31, 2018 and Sep 30, 2026 — classified as 1 death, 87 injuries, 922 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (182 reports).
4 FDA recall records name at least one of these models by its device identifier, 4 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
OES CYSTONEPHROFIBERSCOPE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 4, 2023Open, Classified
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
Z-0685-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Dec 4, 2023Open, Classified
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
Z-0684-2024 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
- Sep 25, 2023Open, Classified
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Z-0331-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Apr 20, 2022Open, Classified
Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis.
Z-1262-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported OES CYSTONEPHROFIBERSCOPE problems
Device problems
- Detachment of Device or Device Component182
- Failure to Clean Adequately147
- Microbial Contamination of Device138
- Device Reprocessing Problem103
- Break79
- Peeled/Delaminated41
- Material Split, Cut or Torn40
- Material Separation33
Patient problems
- No Clinical Signs, Symptoms or Conditions906
- Urinary Tract Infection41
- Unspecified Infection37
- No Patient Involvement16
- Bacterial Infection10
- Fever8
- Hematuria8
- Nausea8
OES CYSTONEPHROFIBERSCOPE models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5Cystoscope and accessories, flexible/rigid1 recall353 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5Cystoscope and accessories, flexible/rigid1 recall1 death332 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5Cystoscope and accessories, flexible/rigid2 recalls75 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5RCystoscope and accessories, flexible/rigid114 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5RCystoscope and accessories, flexible/rigid1 recall54 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5ACystoscope and accessories, flexible/rigid39 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5AFORCEPS, BIOPSY, ELECTRIC24 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5Cystoscope And Accessories, Flexible/Rigid10 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5AKit, nephroscope9 reports
Recent OES CYSTONEPHROFIBERSCOPE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Detachment of Device or Device Component
The customer returned the OES Cystonephrofiberscope for a separate issue. During the initial evaluation of the device it was observed that the bending section cover glue was missing. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951656 ↗MalfunctionSep 29, 2026Environmental Particulates
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934256 ↗MalfunctionSep 25, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903380 ↗MalfunctionSep 25, 2026Stretched
The customer reported the seal/sheath was hanging over the tip of the scope involving an Olympus Cysto Nephro Fiberscope. The issue occurred during reprocessing. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897318 ↗MalfunctionSep 23, 2026Naturally Worn; Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876207 ↗MalfunctionSep 23, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873889 ↗MalfunctionSep 23, 2026Detachment of Device or Device Component
The customer reported the Cystonephrofiberscope had a separate issue. During the initial evaluation of the device it was observed, that the bending section rubber cover had blown off and was missing. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871585 ↗MalfunctionSep 21, 2026Loss of or Failure to Bond
The customer returned the Cysto Nephro Fiberscope for a separate issue. During the initial evaluation of returned device it was found the bending section cover/distal sheath torn off. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841488 ↗MalfunctionSep 21, 2026Stretched
The customer returned the Cysto Nephro Fiberscope for a separate issue. During the initial evaluation of returned device it was found the bending section cover/distal sheath is stretched, bulging. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841325 ↗MalfunctionSep 21, 2026Material Fragmentation
The customer returned the Cysto Nephro Fiberscope for a separate issue. During the initial evaluation of returned device it was found the adhesive of the bending section cover/distal sheath has a chip. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841239 ↗MalfunctionSep 3, 2026Stretched; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50594497 ↗MalfunctionSep 3, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50591665 ↗MalfunctionSep 3, 2026Peeled/Delaminated; Environmental Particulates
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588199 ↗MalfunctionSep 3, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50576972 ↗MalfunctionSep 2, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50573413 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page